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As AI is now used in several different fields, those provisions setting AI legal standards might interact with other Regulations, especially in risky sectors, i.e. healthcare. This paper offers a brief analysis of what standards are to be considered if an AI system was intended to be used as a medical device. It shows the intersection between the Medical Device Regulation and the Artificial Intelligence Act, presenting which opportunities and challenges the new proposal might bring. Three case studies will test the intersection and report the practical outcomes in terms of classifications and obligations.<\/jats:p>","DOI":"10.1007\/s12626-023-00145-z","type":"journal-article","created":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T09:02:22Z","timestamp":1693299742000},"page":"275-295","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Obligation for AI Systems in Healthcare: Prepare for Trouble and Make it Double?"],"prefix":"10.1007","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2691-0611","authenticated-orcid":false,"given":"Marinella","family":"Quaranta","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilaria Angela","family":"Amantea","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Grosso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,8,29]]},"reference":[{"key":"145_CR1","doi-asserted-by":"publisher","first-page":"163","DOI":"10.1007\/978-3-031-08838-4_12","volume-title":"Italian forum of ambient assisted living","author":"IA Amantea","year":"2022","unstructured":"Amantea, I. A., Sulis, E., Boella, G., De Marchi, F., Mazzini, L., Alloatti, F., & Bolioli, A. (2022). Adopting assistive technologies in healthcare processes: A chatbot for patients with amyotrophic lateral sclerosis. Italian forum of ambient assisted living (pp. 163\u2013174). Springer."},{"key":"145_CR2","first-page":"522","volume":"270","author":"IA Amantea","year":"2020","unstructured":"Amantea, I. A., Sulis, E., Boella, G., Marinello, R., Bianca, D., Brunetti, E., Bo, M., & Fernandez-Llatas, C. (2020). A process mining application for the analysis of hospital-at-home admissions. Studies in Health Technology and Informatics, 270, 522\u2013526.","journal-title":"Studies in Health Technology and Informatics"},{"key":"145_CR3","doi-asserted-by":"crossref","unstructured":"Chaudhry, H. A. H., Renzulli, R., Perlo, D., Santinelli, F., Tibaldi, S., Cristiano, C., Grosso, M., Limerutti, G., Fiandrotti, A., Grangetto, M., et\u00a0al. (2022). UniToChest: A lung image dataset for segmentation of cancerous nodules on CT scans. In: Image analysis and processing\u2013ICIAP 2022: 21st international conference, Lecce, Italy, May 23\u201327, 2022, Proceedings, Part I (pp. 185\u2013196). Springer.","DOI":"10.1007\/978-3-031-06427-2_16"},{"key":"145_CR4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2021.119386","volume":"429","author":"F De Marchi","year":"2021","unstructured":"De Marchi, F., Amantea, I. A., Serioli, M., Sulis, E., Boella, G., Alloatti, F., Bolioli, A., Riso, S., Cantello, R., & Mazzini, L. (2021). E-health solutions for amyotrophic lateral sclerosis patients: A chatbot for dietary monitoring. Journal of the Neurological Sciences, 429, 119386.","journal-title":"Journal of the Neurological Sciences"},{"key":"145_CR5","unstructured":"De Streel, A., Bibal, A., Fr\u00e9nay, B., Lognoul, M. (2020). Explaining the black box: When law controls AI. 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A., Sep\u00falveda, M., Helm, E., Galvez-Yanjari, V., Rojas, E., Martinez-Millana, A., Aloini, D., et al. (2022). Process mining for healthcare: Characteristics and challenges. Journal of Biomedical Informatics, 127, 103994.","journal-title":"Journal of Biomedical Informatics"},{"issue":"4","key":"145_CR12","doi-asserted-by":"publisher","first-page":"341","DOI":"10.1163\/15718093-bja10053","volume":"28","author":"S Palmieri","year":"2021","unstructured":"Palmieri, S., Walraet, P., & Goffin, T. (2021). Inevitable influences: AI-based medical devices at the intersection of medical devices regulation and the proposal for AI regulation. European Journal of Health Law, 28(4), 341\u2013358.","journal-title":"European Journal of Health Law"},{"key":"145_CR13","unstructured":"Tietjen, D., von Woedtke, N., Schwind, E. (2021). 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